System and method for motion-controlled foot unit

ABSTRACT

A system and method associated with the movement of a limb. In one example, the system, such as a prosthetic or orthotic system, includes an actuator that actively controls, or adjusts, the angle between a foot unit and a lower limb member. A processing module may control movement of the actuator based on data obtained from a sensor module. For instance, sensing module data may include information relating to the gait of a user and may be used to adjust the foot unit to substantially mimic the movement of a natural, healthy ankle. The system may further accommodate, for example, level ground walking, traveling up/down stairs, traveling up/down sloped surfaces, and various other user movements. In addition, the processing module may receive user input or display output signals through an external interface. For example, the processing module may receive a heel height input from the user.

RELATED APPLICATIONS

The present application claims the benefit of priority under 35 U.S.C. §119(e) of U.S. Provisional Application No. 60/544,259, filed Feb. 12,2004, and entitled “LOWER LIMB PROSTHESIS WITH ANKLE-MOTION-CONTROLLEDFOOT,” and U.S. Provisional Application No. 60/588,232, filed Jul. 15,2004, and entitled “PROSTHETIC OR ORTHOTIC SYSTEM WITHANKLE-MOTION-CONTROLLED FOOT,” each of which is incorporated herein byreference in its entirety and is to be considered a part of thisspecification.

BACKGROUND OF THE INVENTION

1. Field of the Invention

Preferred embodiments of this invention relate to systems and methodshaving a motion-controlled limb and, in particular, anankle-motion-controlled foot.

2. Description of the Related Art

Millions of individuals worldwide rely on prosthetic and/or orthoticdevices to compensate for disabilities, such as amputation ordebilitation, and to assist in the rehabilitation of injured limbs.Orthotic devices include external apparatuses used to support, align,prevent, protect, correct deformities of, or improve the function ofmovable parts of the body. Prosthetic devices include apparatuses usedas artificial substitutes for a missing body part, such as an arm orleg.

The number of disabled persons and amputees is increasing each year asthe average age of individuals increases, as does the prevalence ofdebilitating diseases such as diabetes. As a result, the need forprosthetic and orthotic devices is also increasing. Conventionalorthoses are often used to support a joint, such as an ankle or a knee,of an individual, and movement of the orthosis is generally based solelyon the energy expenditure of the user. Some conventional prostheses areequipped with basic controllers that artificially mobilize the jointswithout any interaction from the amputee and are capable of generatingonly basic motions. Such basic controllers do not take intoconsideration the dynamic conditions of the working environment. Thepassive nature of these conventional prosthetic and orthotic devicestypically leads to movement instability, high energy expenditure on thepart of the disabled person or amputee, gait deviations and other short-and long-term negative effects. This is especially true for leg Qrthosesand prostheses.

SUMMARY OF THE INVENTION

Accordingly, one embodiment of the invention includes a prosthetic ororthotic system that is self-powered and that mimics the naturalmovement of a healthy limb, and in particular, the movement of a healthyankle. Another embodiment of the invention includes a sensor system anda control system that manage the motion of the prosthetic or orthoticsystem so as to facilitate movement by the disabled person or amputee.

One embodiment of the invention includes a system associated with themovement of a limb. In one embodiment, the system comprises a foot unit;an attachment member having an upper end and a lower end, wherein thelower end is pivotably attached to a first location on the foot unit;and an actuator operatively coupled to the foot unit and to theattachment member, wherein the actuator is configured to actively adjustan angle between the attachment member and the foot unit. For example,the foot unit may be a prosthetic or orthotic device.

Another embodiment of the invention includes a prosthetic system formimicking the natural movement of an ankle. In one embodiment, theprosthetic system comprises a prosthetic foot; a pivot assembly attachedto a first position on the prosthetic foot, wherein the first positionis near a natural ankle location of the prosthetic foot; a lower limbmember extending in a tibial direction, the lower limb member having anupper end and a lower end, wherein the lower end of the lower limbmember is operatively coupled to the pivot assembly; and an actuatoroperatively coupled to the prosthetic foot and to the lower limb member,wherein the actuator is configured to actively adjust an angle betweenthe lower limb member and the prosthetic foot about the pivot assembly.

One embodiment of the invention includes a method for controlling adevice associated with the movement of a limb. In one embodiment, themethod comprises monitoring with at least one sensor the movement of anactuatable device associated with a limb; generating data indicative ofsaid movement; processing the data with a processing module to determinea current state of locomotion of the actuatable device; and adjustingthe actuatable device based on the determined state of locomotion,wherein said adjusting comprises substantially mimicking the movement ofa healthy ankle. For example, the actuatable device may be a prosthesisor an orthosis.

Another embodiment of the invention includes a method for controlling aprosthetic ankle device. In one embodiment, the method comprisesmonitoring with at least one sensor the movement of an actuatableprosthetic ankle device, wherein the at least one sensor generates dataindicative of the movement of the prosthetic ankle device; receiving andprocessing the data with a control module to determine a current stateof locomotion of the actuatable prosthetic ankle device; outputting withthe control module at least one control signal based on the determinedstate of locomotion; and adjusting the actuatable prosthetic ankledevice based at least upon the control signal, wherein said adjustingcomprises substantially mimicking the movement of a healthy ankle.

In one embodiment, a prosthetic or orthotic system is provided having anankle-motion-controlled foot. The prosthetic or orthotic systemcomprises, among other things, a lower limb member, an actuator, and afoot unit. The actuator is configured to mimic the motion of an ankle byadjusting the angle between the lower limb member and the foot unit. Theprosthetic or orthotic system also comprises an attachment portion thatfacilitates coupling of the lower limb member to another prosthetic ororthotic member, to the stump of an amputee, or to another component.The prosthetic or orthotic system may also comprise a rechargeablebattery to provide power to the actuator or other components of thesystem. Embodiments of the invention include systems for bothtranstibial and transfemoral amputees.

In another embodiment of the invention, the prosthetic or orthoticsystem comprises a sensor system that is used to capture informationregarding the position and movement of the prosthetic or orthoticdevice. This information may be processed in real-time so as to predictappropriate movements for the prosthetic or orthotic device and toadjust the prosthetic or orthotic device accordingly.

In one embodiment of the invention, a system architecture is providedhaving a sensor module, a central processing unit, a memory, an externalinterface, a control drive module, an actuator, and an ankle device. Thesystem architecture may receive instructions and/or data from externalsources, such as a user or an electronic device, through the externalinterface.

In one embodiment, a control system may also be provided that managesthe movement of the orthosis or the prosthesis. In one embodiment, thecontrol system manages the movement of an actuator, such as a screwmotor. Such motion control provides for movement by the user up inclinedsurfaces, down declines, or on stairs. In one embodiment, the controlsystem may be configured to monitor through sensors the movements of ahealthy limb and use the measurements to control the movement of theprosthesis or orthosis. The control system may also manage the dampingof the actuator or other portions of the orthosis or prosthesis.

In one embodiment, a method is provided for controlling actuation of aprosthetic or orthotic device. The method comprises providing one ormore sensors on an actuatable prosthetic or orthotic device. Datareceived from the sensors is processed and is used to determine thecurrent state of locomotion for the prosthetic device. A processingunit, using at least a portion of the data received from the sensors,then predicts movement of the prosthetic or orthotic device. In oneembodiment, a prosthetic ankle is provided that mimics the movement of ahealthy ankle. The one or more sensors may comprise, for example,gyroscopes and/or accelerometers. In another embodiment of theinvention, adjustments are not made to the actuatable prosthetic ororthotic device unless the locomotion type of the user is determined bythe processing unit to have a security factor above a predeterminedthreshold value.

In another embodiment, a method is provided for identifying motion of anorthotic or prosthetic device. The method comprises receiving data fromone or more sensors placed on an orthotic or prosthetic device while thedevice is moving. A waveform is generated from the data received by thesensors. A specific motion for the orthotic or prosthetic device isidentified by correlating the waveform with known waveforms forparticular types of motion. For example, known waveforms may be inputtedby a user or downloaded from an external device or system. The waveformsmay also be stored in a memory on the prosthetic or orthotic device.

In another embodiment, a method is provided for actuating anankle-assisting device. The device is actuated by providing a computercontrol to provide relative motion between a first and a second portionof the device. In one embodiment, the device is an orthosis. In anotherembodiment, the device is a prosthesis. In one embodiment, the computercontrol predicts future motion of the device. In another embodiment, thecomputer control receives input from at least one sensor module thatreceives information regarding environmental variables and/or themovement or position of the prosthetic or orthotic device. In anotherembodiment, the computer control receives input from at least one sensormodule that receives information regarding the movement or position of ahealthy limb.

For purposes of summarizing the invention, certain aspects, advantagesand novel features of the invention have been described herein. It is tobe understood that not necessarily all such advantages may be achievedin accordance with any particular embodiment of the invention. Thus, theinvention may be embodied or carried out in a manner that achieves oroptimizes one advantage or group of advantages as taught herein withoutnecessarily achieving other advantages as may be taught or suggestedherein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a lower limb prosthesis having anankle-motion-controlled foot unit according to one embodiment of theinvention.

FIG. 2 is a perspective view of the lower limb prosthesis of FIG. 1,wherein a cover is removed to show inner components of the prosthesis.

FIG. 3 is a side view of the lower limb prosthesis of FIG. 2.

FIG. 4 is a rear view of the lower limb prosthesis of FIG. 2.

FIG. 5 is a side view of the lower limb prosthesis of FIG. 1 with thecover shown partially removed, wherein the ankle-motion-controlled footis adjusted to accommodate an incline.

FIG. 6 is a side view of a lower limb prosthesis of FIG. 5, wherein theankle-motion-controlled foot is adjusted to accommodate a decline.

FIG. 7 is a schematic drawing indicating the correlation between anankle pivot point on an exemplifying embodiment of a prosthetic footunit with the natural ankle joint of a human foot.

FIG. 8 is a graph depicting the range of ankle motion of an exemplifyingembodiment of a prosthetic or orthotic system during one full stride ona level surface.

FIG. 9 is a block diagram of an exemplifying embodiment of a controlsystem architecture of a prosthetic or orthotic system having anankle-motion-controlled foot.

FIG. 10 is a table illustrating control signals usable to adjust theankle angle of a prosthetic or orthotic system according to oneembodiment of the invention.

FIG. 11 is a graph depicting an exemplifying embodiment of therelationship between the control of a prosthetic or orthotic system andthe motion of a corresponding sound limb.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Some preferred embodiments of the invention described herein relategenerally to prosthetic and orthotic systems and, in particular, toprosthetic and orthotic devices having an ankle-motion-controlled foot.While the description sets forth various embodiment-specific details, itwill be appreciated that the description is illustrative only and shouldnot be construed in any way as limiting the invention. Furthermore,various applications of the invention, and modifications thereto, whichmay occur to those who are skilled in the art, are also encompassed bythe general concepts described herein.

The features of the system and method will now be described withreference to the drawings summarized above. Throughout the drawings,reference numbers are re-used to indicate correspondence betweenreferenced elements. The drawings, associated descriptions, and specificimplementation are provided to illustrate embodiments of the inventionand not to limit the scope of the invention.

The terms “prosthetic” and “prosthesis” as used herein are broad termsand are used in their ordinary sense and refer to, without limitation,any system, device or apparatus usable as an artificial substitute orsupport for a body part.

The term “orthotic” and “orthosis” as used herein are broad terms andare used in their ordinary sense and refer to, without limitation, anysystem, device or apparatus usable to support, align, prevent, protect,correct deformities of, immobilize, or improve the function of parts ofthe body, such as joints and/or limbs.

The term “ankle device” as used herein is a broad term and is used inits ordinary sense and relates to any prosthetic, orthotic orankle-assisting device.

The term “transtibial” as used herein is a broad term and is used in itsordinary sense and relates to without limitation any plane, direction,location, or cross-section that is located at or below a knee joint of abody, including artificial knee joints.

The term “transfemoral” as used herein is a broad term and is used inits ordinary sense and relates to without limitation any plane,direction, location, or cross-section that is located at or above a kneejoint of a body, including artificial knee joints.

The term “sagittal” as used herein is a broad term and is used in itsordinary sense and relates to any description, location, or directionrelating to, situated in, or being in or near the median plane (i.e.,the plane divides the body lengthwise into right and left halves) of thebody or any plane parallel or approximately parallel thereto. A“sagittal plane” may also refer to any vertical anterior to posteriorplane that passes through the body parallel or approximately parallel tothe median plane and that divides the body into equal or unequal rightand left sections.

The term “coronal” as used herein is a broad term and is used in itsordinary sense and relates to any description, location, or directionrelating to, situated in, or being in or near the plane that passesthrough the long axis of the body. A “coronal plane” may also refer toany plane that passes vertically or approximately vertically through thebody and is perpendicular or approximately perpendicular to the medianplane and that divides the body into anterior and posterior sections.

FIG. 1 illustrates one embodiment of a lower limb prosthesis 100 havingan ankle-motion-controlled foot with an attachment member. Theprosthesis 100 comprises an attachment member, in the form of a lowerlimb member 102, operatively coupled to a foot unit 104. As used herein,the term “attachment member” is a broad term and is used in its ordinarysense and in a prosthetic foot embodiment relates to, withoutlimitation, any member that attaches either directly or indirectly tothe foot unit 104 and is moveable in relation thereto, for example by apivoting motion, and is used to attach the prosthesis 100 to a stump orintermediate prosthesis. As illustrated, the attachment member may takethe form of a lower limb member in an ankle-prosthesis embodiment. Inother embodiments, for example an orthotic embodiment, the attachmentmember may be used to attach to and support a body part, such as with abrace, which also is moveably connected to a second member, such as afoot unit, which would also attach to and support a body part, such asthe foot. In one embodiment, the lower limb member 102 is a generallyelongated member with a main longitudinal axis that extends inapproximately a tibial direction, that is, a direction that extendsgenerally along the axis of a natural tibia bone. For example, FIG. 1depicts the lower limb member 102 as being a generally verticalorientation.

In another embodiment, the lower limb member 102 may comprise multiplesections. For example, the lower limb member 102 may comprise twoelongated sections that extend approximately parallel in a tibialdirection and that are connected together. In another embodiment, thelower limb member 102 comprises a two-sided chamber having twosubstantially symmetrical parts to form a partially enclosed housing. Inanother embodiment, the lower limb member 102 may comprise a hollowmember, such as a tube-like structure. In other embodiments, the lowerlimb member 102 may comprise elongated flat portions or roundedportions. In yet other embodiments, the structure of the lower limbmember 102 is not elongated. For example, the lower limb member 102 maycomprise a generally circular, cylindrical, half-circular, dome-shaped,oval or rectangular structure. One example of a possible lower limbmember is the ankle module and the structures described in U.S. patentapplication Ser. No. 10/742,455, filed Dec. 18, 2003, and entitled“PROSTHETIC FOOT WITH ROCKER MEMBER,” the entirety of which is herebyincorporated herein by reference and is to be considered as part of thisspecification.

In one embodiment, the lower limb member 102 is generally formed of amachine metal, such as aluminum, or a carbon fiber material. In otherembodiments of the invention, the lower limb member 102 may compriseother materials that are suitable for prosthetic devices. In oneembodiment, the lower limb member 102 advantageously has a heightbetween approximately 12 and 15 centimeters. In other embodiments of theinvention, the lower limb member 102 may have a height less than 12centimeters or height greater than 15 centimeters depending on the sizeof the user and/or the intended use of the prosthesis 100. For example,the lower limb member 102 may have a height of approximately 20centimeters.

In one embodiment, the prosthesis 100 is configured such that the mainlongitudinal axis of the lower limb member 102 is substantiallyperpendicular to a lower surface of the foot unit 104 when theprosthesis 100 is in a resting position. In another embodiment, thelower limb member 102 may be substantially perpendicular to a levelground surface when the foot unit 104 rests on the ground. Such aconfiguration advantageously provides a user with increased supportand/or stability.

As depicted in FIG. 1, the lower limb member 102 further comprises acover 106. The cover 106 houses and/or protects the inner components ofthe lower limb member 102. In another embodiment, the cover 106 may berounded or may be shaped in the form of a natural human leg.

The lower limb member 102 further comprises an attachment portion 108 tofacilitate coupling of the lower limb member 102. For example, asdepicted in FIG. 1, the attachment portion 108 of the lower limb member102 couples the prosthesis 100 to a pylon 110. In other embodiments ofthe invention, the attachment portion 108 may be configured to couplethe prosthesis 100 to a stump of an amputee or to another prostheticdevice. FIG. 1 also depicts a control wire 112 usable to provide powerto and/or communicate control signals to the prosthesis 100.

The foot unit 104 may comprise various types of prosthetic or orthoticfeet. As illustrated in FIG. 1, the foot unit 104 incorporates a designdescribed in Applicant's co-pending U.S. patent application Ser. No.10/642,125, entitled “LOW PROFILE PROSTHETIC FOOT,” and filed Aug. 15,2003 the entirety of which is hereby incorporated by reference and is tobe considered as part of this specification. For example, the foot unit104 may comprise a standard LP VARI-FLEX® unit available from Ossur.

In one embodiment, the foot unit 104 is configured to exert aproportional response to weight or impact levels on the foot unit 104.In addition, the foot unit 104 may comprise shock absorption forcomfortable loading of the heel and/or for returning expended energy.The foot unit 104 may comprise a full-length toe lever with enhancedflexibility so as to provide a stride length for the prosthetic limbthat mimics the stride length of the healthy limb. In addition, asdepicted in FIG. 1, the foot unit 104 may comprise a split-toeconfiguration, which facilitates movement on uneven terrain. The footunit 104 may also include a cosmesis or a foot cover such as, forexample, a standard Flex-Foot cover available from Ossur.

FIG. 2 depicts the prosthesis 100 with the cover 106 removed. As shown,a lower end of the lower limb member 102 is coupled to the foot unit 104at a pivot assembly 114. As illustrated, the lower limb member 102 iscoupled to an ankle plate of the foot unit 104, which extends generallyrearward and upward from a toe portion of the foot unit 104. The pivotassembly 114 allows for angular movement of the foot unit 104 withrespect to the lower limb member 102. For example, in one embodiment,the pivot assembly 114 advantageously comprises at least one pivot pin.In other embodiments, the pivot assembly 114 comprises a hinge, amulti-axial configuration, a polycentric configuration, combinations ofthe same or the like. Preferably, the pivot assembly 114 is located on aportion of the foot unit 104 that is near a natural ankle location ofthe foot unit 104. In other embodiments of the invention, the pivotassembly 114 may be bolted or otherwise releasably connected to the footunit 104.

FIG. 2 further depicts the prosthesis 100 having an actuator 116. In oneembodiment, the actuator 116 advantageously provides the prosthesis 100with the necessary energy to execute angular displacements synchronizedwith the amputee's locomotion. For example, the actuator 116 may causethe foot unit 104 to move similar to a natural human foot. In oneembodiment, the lower end of the actuator 116 is coupled to the footunit 104 at a first attachment point 118. As illustrated, the footattachment point 118 is advantageously located on the upper surface ofthe foot unit 104 on a posterior portion thereof. The upper end of theactuator 116 is coupled to the lower limb member 102 at a secondattachment point 120.

In one embodiment, the linear motion (or extension and contraction) ofthe actuator 116 controls, or actively adjusts, the angle between thefoot unit 104 and the lower limb member 102. FIG. 2 depicts the actuator116 comprising a double-screw motor, wherein the motor pushes or pulls aposterior portion of the foot unit 104 with respect to the lower limbmember 102. In other embodiments, the actuator 116 comprises othermechanisms capable of actively adjusting an angle, or providing formotion between, multiple members. For example, the actuator 116 maycomprise a single-screw motor, a piston cylinder-type structure, aservomotor, a stepper motor, a rotary motor, a spring, a fluid actuator,or the like. In yet other embodiments, the actuator 116 may activelyadjust in only one direction, the angle between the lower limb member102 and the foot unit 104. In such an embodiment, the weight of the usermay also be used in controlling the angle caused by and/or the movementof the actuator 116.

FIG. 2 illustrates the actuator 116 in a posterior configuration,wherein the actuator 116 is located behind the lower limb member 102. Inother embodiments, the actuator 116 may be used in an anteriorconfiguration, wherein the actuator 116 is located in front of the lowerlimb member 102. In another embodiment of the invention, the actuator116 comprises an auto adjusting ankle structure and incorporates adesign, such as described in U.S. Pat. No. 5,957,981, the entirety ofwhich is hereby incorporated by reference and is to be considered as apart of this specification. The particular configuration or structuremay be selected to most closely imitate the movement and location of anatural human ankle joint and to facilitate insertion of the prosthesis100 into an outer cosmesis.

Furthermore, the actuator 116 is advantageously configured to operate soas to not to emit loud noises, such as intermittent noises, perceptibleby the user and/or others. The actuator 116 may also be configured tonot operate or adjust if the prosthesis 100 experiences torque, such asin the sagittal plane, that exceeds a certain level. For example, if thetorque level exceeds four Newton meters (Nm), the actuator 116 may ceaseto operate or may issue an alarm.

The actuator 116 may also be substantially enclosed within the cover 106as shown in FIG. 1 such that the portions of the actuator 116 are notvisible and/or exposed to the environment. In another embodiment, theactuator may be at least partially enclosed by the lower limb member102.

FIG. 2 further depicts control circuitry 122 usable to control theoperation of the actuator 116 and/or the foot unit 104. In oneembodiment, the control circuitry 122 comprises at least one printedcircuit board (PCB). The PCB may further comprise a microprocessor.Software may also reside on the PCB so as to perform signal processingand/or control the movement of the prosthesis 100.

In one embodiment, the prosthesis 100 includes a battery (not shown)that powers the control circuitry 122 and/or the actuator 116. In oneembodiment, the battery comprises a rechargeable lithium ion batterythat preferably has a power cycle of at least 12 to 16 hours. In yetother embodiments, the power cycle of the battery may be less than 12hours or may be more than 16 hours. In other embodiments of theinvention, the battery comprises a lithium polymer battery, fuel celltechnology, or other types of batteries or technology usable to providepower to the prosthesis 100. In yet other embodiments, the battery isremovably attached to a rear surface of the lower limb member 102, toother portions of the prosthesis 100, or is located remote theprosthesis 100. In further embodiments, the prosthesis 100 may beconnected to an external power source, such as through a wall adapter orcar adapter, to recharge the battery.

In one embodiment, the prosthesis 100 is configured to lock in a neutralposition, such as the lower limb member 102 being aligned generallyvertical relative to a level ground surface when the foot unit 104 isresting on the level ground surface, when the battery is out of power orenters a low power stage. Such locking provides for operational safety,reliability, and/or stability for a user. The prosthesis 100 may alsoprovide a battery status display that alerts the user as to the status(i.e., charge) of the battery. In another embodiment, the prosthesis 100locks into a substantially neutral position when the motion controlfunctions of the prosthesis 100 are turned off or disabled by a user.

As discussed above, a cosmesis material or other dressings may be usedwith the prosthesis 100 so as to give the prosthesis 100 a more naturallook or shape. In addition, the cosmesis, dressings, or other fillermaterial may be used to prevent contaminants, such as dirt or water,from contacting the components of the prosthesis 100.

FIG. 3 depicts a side view of the prosthesis 100 according to oneembodiment of the invention. As depicted in FIG. 3, the actuator 116further comprises a main housing 124, a lower extendable portion 126,and an upper extendable portion 128. The lower extendable portion 126couples the main housing 124 of the actuator 116 to the foot unit 104 atthe first attachment point 118. The upper extendable portion 128 couplesthe main housing 124 of the actuator 116 to the lower limb member 102 atthe second attachment point 120. During operation and active adjustmentof the prosthesis 100, the lower extendable portion 126 and/or the upperextendable portion 128 move into and/or out of the main housing 124 ofthe actuator 116 to adjust an angle between the foot unit 104 and thelower limb member 102.

For example, to increase an angle between the foot unit 104 and thelower limb member 102, the actuator 116 causes the lower extendableportion 126 and/or the upper extendable portion 128 to contract orwithdraw into the main housing 124. For example, at least one of theextendable portions 126, 128 may have a threaded surface such thatrotation in one direction (e.g., clockwise) causes the extendableportion to withdraw into the main housing 124 of the actuator. In otherembodiments, at least one of the extendable portions 126, 128 comprisesmultiple telescoping pieces such that, upon contraction, one of themultiple pieces of extendable portion contracts into another of themultiple pieces without withdrawing into the main housing 124. Likewise,to decrease an angle between the foot unit 104 and the lower limb member102, the lower extendable portion 126 and/or the upper extendableportion 128 may extend from the main housing 124.

In embodiments of the invention having an anterior configuration for theactuator 116, extension of the lower extendable portion 126 and/or theupper extendable portion 128 causes an increase in the angle between thelower limb member 102 and the foot unit 104. Likewise, a contraction ofthe lower extendable portion 126 and/or the upper extendable portion 128causes a decrease in the angle between the foot unit 104 and the lowerlimb member 102.

FIG. 4 illustrates a rear view of the prosthesis 100 depicted in FIGS.1-3. In other embodiments of the invention, the cover 106 extends aroundthe posterior portion of the prosthesis 100 to house at least a portionof the actuator 116 such that portions of the actuator 116 are notvisible and/or not exposed to the environment.

FIGS. 5 and 6 illustrate one embodiment of the prosthesis 100 as itadjusts to inclines and declines. With reference to FIG. 5, theprosthesis 100 is depicted as adjusting to an incline. In thisembodiment, the actuator 116 extends so as to decrease an angle 0between the lower limb member 102 and the foot unit 104 (or“dorsiflexion”). With respect to dorsiflexion, in one embodiment, theangular range of motion of the prosthesis 100 is from about 0 to 10degrees from the neutral position. Other embodiments may also facilitateexaggerated dorsiflexion during swing phase.

FIG. 6 illustrates the prosthesis 100 as it adjusts to a decline. Theactuator 116 extends so as to increase the angle θ between the lowerlimb member 102 and the foot unit 104 (or “plantarflexion”). Withrespect to plantarflexion, in one embodiment, the angular range ofmotion of the prosthesis 100 is from about 0 to 20 degrees from theneutral position. Such plantarflexion mimics natural ankle movement andprovides for greater stability to an amputee or a user. In oneembodiment, the total range of motion about the ankle pivot axis of theprosthesis 100, including both plantarflexion and dorsiflexion, isapproximately 30 degrees or more.

In addition to operating on inclines and declines, the motion-controlledfoot of the prosthesis 100 advantageously accommodates differentterrain, operates while traveling up and down stairs, and facilitateslevel ground walking. In addition, the prosthesis 100 may provide forautomatic heel height adjustability. Heel height may be measured, in oneembodiment, from an ankle portion of the lower limb member 102 to aground surface when the foot unit 104 is generally flat to the ground.For example, a user may adjust to various heel heights, such as throughpressing one or more buttons, such that the prosthesis 100 automaticallyaligns itself to the appropriate heel height. In one embodiment, theprosthesis 100 includes a plurality of predetermined heel heights. Inyet other embodiments, the prosthesis 100 may automatically adjust theheel height without the need for user input.

FIGS. 5 and 6 further illustrate one embodiment of the attachmentportion 108. The attachment portion 108 provides alignment between thenatural limb of the amputee and the prosthesis 100 and may be configuredso as to decrease pressure peaks and shear forces. For example, theattachment portion 108 may be configured to attach to anotherprosthesis, to the stump of the amputee, or to another component. In oneembodiment, the attachment portion 108 comprises a socket connector. Thesocket connector may be configured to receive a 32 mm-thread component,a male pyramid type coupler, or other components. In other embodiments,the attachment portion 108 may also comprise, or be configured toreceive, a female pyramid adapter.

As depicted in FIGS. 5 and 6, the pivot assembly 114 is positioned tomimic a normal human ankle axis. FIG. 7 further illustrates a schematicdrawing indicating the correlation between an ankle pivot point on aprosthetic foot unit 204 with the natural human ankle joint of a foot.In particular, the prosthetic foot unit 204 comprises a pivot assembly214 that corresponds to an ankle joint 240 of a human foot 242. Forexample, in one embodiment of the invention, the pivot assembly 114 islocated near the mechanical ankle center of rotation of the prosthesis100.

FIG. 8 illustrates a graph depicting the possible range of ankle motionof an embodiment of the prosthesis 100 during one full stride on a levelsurface. As shown, the x-axis of the graph represents various pointsduring one full stride of a user (i.e., 0 to 100 percent). The y-axisrepresents the ankle angle (θ) of the prosthesis 100. During one fullstride, the ankle angle (θ) varies from approximately 20 degreesplantarflexion (i.e., neutral position angle+20 degrees) toapproximately 10 degrees dorsiflexion (i.e., neutral position angle−20degrees).

In embodiments as described above, no dampening is provided whenadjusting the angular range of motion. In another embodiment of theinvention, the prosthesis 100 is configured to provide dampening orpassive, soft resistance to changes in the angle between the lower limbmember 102 and the foot unit 104. An example of a system for controllingsuch dampening is disclosed in U.S. Pat. No. 6,443,993, which is herebyincorporated herein by reference and is to be considered as a part ofthis specification.

For example, when the user is in a standing position, the actuator 116may provide for increased resistance, or dampening, so as to providestability to the user. In one embodiment of the invention, dampening ofthe prosthesis 100 may be provided by hydraulic dampers. In otherembodiments of the invention, other components or devices that are knownin the art may be used to provide dampening for the prosthesis 100. Inaddition, in one embodiment of the invention, the dampers may bedynamically controlled, such as through an electronic control system,which is discussed in more detail below. In yet other embodiments, thedampers may be controlled through mechanical and/or fluid-typestructures.

It is also recognized that, although the above description has beendirected generally to prosthetic systems and devices, the descriptionmay also apply to an embodiment of the invention having an orthoticsystem or device. For example, in one embodiment of the invention, anorthotic system may comprise at least one actuator that activelycontrols the angle of an orthosis that is used with an injured ordebilitated ankle. In addition, the orthotic system may, in addition tothe electronic control of the orthotic system, provide for the user'scontrol or natural movement of the injured ankle or leg.

In addition, the above-described systems may be implemented inprosthetic or orthotic systems other than transtibial, orbelow-the-knee, systems. For example, in one embodiment of theinvention, the prosthetic or orthotic system may be used in atransfemoral, or above-the-knee, system, such as is disclosed in U.S.Provisional Application No. 60/569,512, filed May 7, 2004, and entitled“MAGNETORHEOLOGICALLY ACTUATED PROSTHETIC KNEE” and U.S. ProvisionalApplication No. 60/624,986, filed Nov. 3, 2004, and entitled“MAGNETORHEOLOGICALLY ACTUATED PROSTHETIC KNEE”, each of which is herebyincorporated herein by reference in its entirety and is to be consideredas part of this specification. For example, the prosthetic or orthoticsystem may include both a prosthetic or orthotic ankle and/or aprosthetic or orthotic knee.

FIG. 9 illustrates a block diagram of one embodiment of a systemarchitecture of a control system 300 for an ankle-motion-controlledfoot. In one embodiment of the invention, the control system 300 isusable by the lower limb prosthesis 100 depicted in FIGS. 1-6. In otherembodiments of the invention the control system 300 is usable by anorthotic system or a rehabilitation system having anankle-motion-controlled foot, or other motion-controlled limb. In oneembodiment, the control system 300 is based on a distributed processingsystem wherein the different functions performed by the prosthetic ororthotic system, such as sensing, data processing, and actuation, areperformed or controlled by multiple processors that communicate witheach other. With reference to FIG. 9, the control system 300 includes asensor module 302, an ankle device 304 (such as, for example, theprosthesis 100 depicted in FIG. 1), a central processing unit (“CPU”)305, a memory 306, an interface module 308, a control drive module 310,an actuator 316 and a power module 318.

In one embodiment, the control system 300 depicted in FIG. 9 processesdata received from the sensing module 302 with the CPU 305. The CPU 305communicates with the control drive module 310 to control the operationof the actuator 316 so as to mimic natural ankle movement by the ankledevice 304. Furthermore, the control system 300 may predict how theankle device 304 may need to be adjusted in order to accommodatemovement by the user. The CPU 305 may also receive commands from a userand/or other device through the interface module 308. The power module318 provides power to the other components of the control system 300.Each of these components is described in more detail below.

In one embodiment, the sensor module 302 is used to measure variablesrelating to the ankle device 304, such as the position and/or themovement of the ankle device 304 throughout a gait cycle. In such anembodiment the sensor module 320 is advantageously located on the ankledevice 304. For example, the sensor module 302 may be located near amechanical ankle center of rotation of the ankle device 304, such as thepivot assembly 114 of the prosthesis 100 depicted in FIG. 2. In anotherembodiment, the sensor module 302 may be located on the user's naturallimb that is attached to, or associated with, the ankle device 304. Insuch an embodiment, the sensors are used to capture information relatingto the movement of the natural limb on the user's ankle-device side toadjust the ankle device 304.

In one embodiment, the sensor module 302 advantageously includes aprinted circuit board housing, multiple sensors, such as accelerometers,which each measures an acceleration of the ankle device 304 in adifferent axis. For example, the sensor module 302 may comprise threeaccelerometers that measure acceleration of the ankle device 304 inthree substantially, mutually perpendicular axes. Sensors of the typesuitable for the sensor module 302 are available from, for example,Dynastream Innovations, Inc. (Alberta, Canada).

In other embodiments, the sensor module 302 may include one or moreother types of sensors in combination with, or in place of,accelerometers. For example, the sensor module 302 may include agyroscope configured to measure the angular speed of body segmentsand/or the ankle device 304. In other embodiments, the sensor module 302includes a plantar pressure sensor configured to measure, for example,the vertical plantar pressure of a specific underfoot area. In yet otherembodiments, the sensor module 302 may include one or more of thefollowing: kinematic sensors, single-axis gyroscopes, single- ormulti-axis accelerometers, load sensors, flex sensors or myoelectricsensors that may be configured to capture data from the user's naturallimb. U.S. Pat. No. 5,955,667, U.S. Pat. No. 6,301,964, and U.S. Pat.No. 6,513,381, also illustrate examples of sensors that may be used withembodiments of the invention, which patents are herein incorporated byreference in their entireties and are to be considered as part of thisspecification.

Furthermore, the sensor module 302 may be used to capture informationrelating to, for example, one or more of the following: the position ofthe ankle device 304 with respect to the ground; the inclination angleof the ankle device 304; the direction of gravity with respect to theposition of the ankle device 304; information that relates to a strideof the user, such as when the ankle device 304 contacts the ground(e.g., “heel strike”), is in mid-stride, or leaves the ground (e.g.,“toe-off”), the distance from the ground of the prosthesis 100 at thepeak of the swing phase (i.e., the maximum height during the swingphase); the timing of the peak of the swing phase; and the like.

In yet other embodiments, the sensor module 302 is configured to detectgait patterns and/or events. For example, the sensor module 302 maydetermine whether the user is in a standing/stopped position, is walkingon level ground, is ascending and/or descending stairs or slopedsurfaces, or the like. In other embodiments, the sensor module 302 isconfigured to detect or measure the heel height of the ankle device 304and/or determine a static shank angle in order to detect when the useris in a sitting position.

As depicted in FIG. 9, in one embodiment of the invention, the sensormodule 302 is further configured to measure environmental or terrainvariables including one or more of the following: the characteristics ofthe ground surface, the angle of the ground surface, the air temperatureand wind resistance. In one embodiment, the measured temperature may beused to calibrate the gain and/or bias of other sensors.

In other embodiments, the sensor module 302 captures information aboutthe movement and/or position of a user's natural limb, such as a healthyleg. In such an embodiment, it may be preferable that when operating onan incline or a decline, the first step of the user be taken with thehealthy leg. Such would allow measurements taken from the naturalmovement of the healthy leg prior to adjusting the ankle device 304. Inone embodiment of the invention, the control system 300 detects the gaitof the user and adjusts the ankle device 304 accordingly while the ankledevice 304 is in a swing phase of the first step. In other embodimentsof the invention, there may be a latency period in which the controlsystem 300 requires one or two strides before being able to accuratelydetermine the gait of the user and to adjust the ankle device 304appropriately.

In one embodiment of the invention, the sensor module 302 has a defaultsampling rate of 100 hertz (Hz). In other embodiments, the sampling ratemay be higher or lower than 100 Hz or may be adjustable by a user, ormay be adjusted automatically by software or parameter settings. Inaddition, the sensor module 302 may provide for synchronization betweentypes of data being sensed or include time stamping. The sensors mayalso be configured so as to have an angular resolution of approximately0.5 degrees, allowing for fine adjustments of the ankle device 304.

In one embodiment, the sensor module 302 is configured to power downinto a “sleep” mode when sensing is not needed, such as for example,when the user is relaxing while in a sitting or reclining position. Insuch an embodiment, the sensor module 302 may awake from the sleep stateupon movement of the sensor module 302 or upon input from the user. Inone embodiment, the sensor module 302 consumes approximately 30milliamps (mA) when in an “active” mode and approximately 0.1 mA when ina “sleep” mode.

FIG. 9 illustrates the sensor module 302 communicating with the CPU 305.In one embodiment, the sensor module 302 advantageously providesmeasurement data to the CPU 305 and/or to other components of thecontrol system 300. In one embodiment, the sensor module 302 is coupledto a transmitter, such as, for example, a Bluetooth® transmitter, thattransmits the measurements to the CPU 305. In other embodiments, othertypes of transmitters or wireless technology may be used, such asinfrared, WiFi®, or radio frequency (RF) technology. In otherembodiments, wired technologies may be used to communicate with the CPU305.

In one embodiment, the sensor module 302 sends a data string to the CPU305 that comprises various types of information. For example, the datastring may comprise 160 bits and include the following information:

-   -   [TS; AccX; AccY; AccZ; GyroX, GyroY, GyroZ, DegX, DegY, FS, M];    -   wherein TS=Timestamp; AccX=linear acceleration of foot along X        axis; AccY=linear acceleration of foot along Y axis; AccZ=linear        acceleration of foot along Z axis; GyroX=angular acceleration of        foot along X axis; GyroY=angular acceleration of foot along Y        axis; GyroZ=angular acceleration of foot along Z axis; DegX=foot        inclination angle in coronal plane; DegY=foot inclination angle        in sagittal plane; FS=logic state of switches in the ankle        device 304; and M=orientation of the sensors. In other        embodiments of the invention, other lengths of data strings        comprising more or less information may be used.

The CPU 305 advantageously processes data received from other componentsof the control system 300. In one embodiment of the invention, the CPU305 processes information relating to the gait of the user, such asinformation received from the sensor module 302, determines locomotiontype (i.e., gait pattern), and/or sends commands to the control drivemodule 310. For example, the data captured by the sensor module 302 maybe used to generate a waveform that portrays information relating to thegait or movement of the user. Subsequent changes to the waveform may beidentified by the CPU 305 to predict future movement of the user and toadjust the ankle device 304 accordingly. In one embodiment of theinvention, the CPU 305 may detect gait patterns from as slow as 20 stepsper minute to as high as 125 steps per minute. In other embodiments ofthe invention, the CPU 305 may detect gait patterns that are slower than20 steps per minute or higher than 125 steps per minute.

In one embodiment of the invention, the CPU 305 processes data relatingto state transitions according to the following table (TABLE 1). Inparticular, TABLE 1 shows possible state transitions usable with thecontrol system 300. The first column of TABLE 1 lists possible initialstates of the ankle device 304, and the first row lists possible secondstates of the ankle device 304. The body of TABLE 1 identifies thesource of data used by the CPU 305 in controlling, or activelyadjusting, the actuator 316 and the ankle device 304 during thetransition from a first state to a second state; wherein “N” indicatesthat no additional data is needed for the state transition; “L”indicates that the CPU 305 uses transition logic to determine theadjustments to the ankle device 304 during the state transition; and “I”indicates the CPU receives data from an interface (e.g., interfacemodule 308, external user interface, electronic interface or the like).Transition logic usable with embodiments of the invention may bedeveloped by one with ordinary skill in the relevant art. Examples oftransition logic used in similar systems and methods to embodiments ofthe present invention are disclosed in U.S. Provisional Application No.60/572,996, entitled “CONTROL SYSTEM AND METHOD FOR A PROSTHETIC KNEE,”filed May 19, 2004, which is hereby incorporated herein by reference andis to be considered as a part of this specification. TABLE 1 TRANSITIONSHEEL_(—) FROM STATE HEIGHT TO STATE OFF _CAL SENSOR_CAL NEUTRAL WALKSTAIRS_UP STAIRS_DOWN RELAX PANTS OFF N I I I N N N I I HEEL_HEIGHT _CALL N N L N N N N N SENSOR_CAL L N N L N N N N N NEUTRAL I I I N L L L L IWALK I N N L N L L N N STAIRS_UP I N N L L N L N N STAIRS_DOWN I N N L LL N N N RELAX I N N L N N N N I PANTS I N N I N N N N N

In one embodiment, the above described states in TABLE 1 are predefinedstates of the ankle device 304. For example, the “OFF” state mayindicate that the functions of the ankle device 304 and the actuator 316are in an off or suspend mode. The “HEEL_HEIGHT_CAL” state relates tothe measuring of a heel height from a static sensor angle such as, forexample, when the ankle device 304 is not in motion. The “SENSOR_CAL”state relates to surface angle calibration when the user is walking on alevel surface. The “NEUTRAL” state relates to when the ankle device 304is locked in a substantially fixed position. The “WALK” state relates towhen the user is walking, such as on a level or sloped surface. “The“STAIRS_UP” and “STAIRS_DOWN” states relate to when the user is walking,respectively, up and down stairs. The “RELAX” state relates to when theuser is in a relaxed position. For example, in one embodiment, the“RELAX” state relates to when a user is in a sitting position with thelimb having the ankle device 304 crossed over the other limb. In such anembodiment, the control system 300 may cause the ankle device 304 tomove into a maximum plantarflexion position to mimic, for example, thenatural position and/or look of a healthy foot. The “PANTS” staterelates to when a user is putting on pants, trousers, shorts or thelike. In such a state, the control system 300 may, in one embodiment,cause the ankle device 304 to move into a maximum plantarflexionposition to facilitate putting the clothing on over the ankle device304.

In other embodiments of the invention, other states are usable with theankle device 304 in place of, or in combination with, the statesidentified in TABLE 1. For example, states may be defined thatcorrespond to lying down, cycling, climbing a ladder or the like.Furthermore, in controlling the state transitions, the CPU 305 and/orcontrol system 300 may process or derive data from sources other thanthose listed in TABLE 1.

In other embodiments, the CPU 305 may perform a variety of otherfunctions. For example, the CPU 305 may use information received fromthe sensor module 302 to detect stumbling by the user. The CPU 305 mayfunction as a manager of communication between the components of thecontrol system 300. For example, the CPU 305 may act as the masterdevice for a communication bus between multiple components of thecontrol system 300. As illustrated, in one embodiment, the CPU 305communicates with the power module 318. For example, the CPU 305 mayprovide power distribution and/or conversion to the other components ofthe control system 300 and may also monitor battery power or batterylife. In addition, the CPU 305 may function so as to temporarily suspendor decrease power to the control system 300 when a user is in a sittingor a standing position. Such control provides for energy conservationduring periods of decreased use. The CPU 305 may also process errorhandling, such as when communication fails between components, anunrecognized signal or waveform is received from the sensor module 302,or when the feedback from the control drive module 310 or the ankledevice 304 causes an error or appears corrupt.

In yet other embodiments of the invention, the CPU 305 uses or computesa security factor when analyzing information from the sensor module 302and/or sending commands to the control drive module 310. For example,the security factor may include a range of values, wherein a highervalue indicates a higher degree of certainty associated with adetermined locomotion type of the user, and a lower security factorindicates a lower degree of certainty as to the locomotion type of theuser. In one embodiment of the invention, adjustments are not made tothe ankle device 304 unless the locomotion type of the user isrecognized with a security factor above a predetermined threshold value.

In one embodiment, the CPU 305 includes modules that comprise logicembodied in hardware or firmware, or that comprise a collection ofsoftware instructions written in a programming language, such as, forexample C++. A software module may be compiled and linked into anexecutable program, installed in a dynamic link library, or may bewritten in an interpretive language such as BASIC. It will beappreciated that software modules may be callable from other modules orfrom themselves, and/or may be invoked in response to detected events orinterrupts. Software instructions may be embedded in firmware, such asan EPROM or EEPROM. It will be further appreciated that hardware modulesmay be comprised of connected logic units, such as gates and flip-flops,and/or may be comprised of programmable units, such as programmable gatearrays or processors.

FIG. 9 further depicts CPU 305 including a memory 306 for storinginstructions and/or data. For example, the memory 306 may store one ormore of the following types of data or instructions: an error log forthe other components of the control system 300; information regardinggait patterns or curves; information regarding past activity of the user(e.g., number of steps); control parameters and set points; informationregarding software debugging or upgrading; preprogrammed algorithms forbasic movements of the prosthetic or orthotic system; calibration valuesand parameters relating to the sensor module 302 or other components;instructions downloaded from an external device; combinations of thesame or the like.

The memory 306 may comprise any buffer, computing device, or systemcapable of storing computer instructions and/or data for access byanother computing device or a computer processor. In one embodiment, thememory 306 is a cache that is part of the CPU 305. In other embodimentsof the invention, the memory 306 is separate from the CPU 305. In otherembodiments of the invention, the memory 306 comprises random accessmemory (RAM) or may comprise other integrated and accessible memorydevices, such as, for example, read-only memory (ROM), programmable ROM(PROM), and electrically erasable programmable ROM (EEPROM). In anotherembodiment, the memory 306 comprises a removable memory, such as amemory card, a removable drive, or the like.

In one embodiment, the CPU 305 may also be configured to receive throughthe interface module 308 user- or activity-specific instructions from auser or from an external device. The CPU 305 may also receive updates toalready existing instructions. Furthermore, the CPU 305 may communicatewith a personal computer, a personal digital assistant, or the like soas to download or receive operating instructions. Activity-specificinstructions may include, for example, data relating to cycling,driving, ascending or descending a ladder, adjustments from walking insnow or sand, or the like.

In one embodiment, the interface module 308 comprises an interface thatthe user accesses so as to control or manage portions or functions ofthe prosthetic or orthotic system. In one embodiment, the interfacemodule 308 is a flexible keypad having multiple buttons and/or multiplelight emitting diodes (LEDs) usable to receive information from and/orconvey information to a user. For example, the LEDs may indicate thestatus of a battery or may convey a confirmation signal to a user. Theinterface module 308 may be advantageously located on the ankle device304. Furthermore, the interface module 308 may comprise a USB connectorusable for communication to an external computing device, such as apersonal computer.

In a further embodiment, the interface module 308 comprises an on/offswitch. In another embodiment, the interface module 308 may receiveinput regarding the user-controlled heel height or a forced relaxed modeof the prosthetic or orthotic system. In other embodiments, the user mayadjust the type of response desired of the prosthesis or enable/disableparticular functions of the ankle device 304. The input from the usermay be entered directly via the interface module 308, such as throughactuating a button, or user input may be received via a remote control.

The interface module 308 may comprise a touch screen, buttons, switches,a vibrator, an alarm, or other input-receiving or output structures ordevices that allow a user to send instructions to or receive informationfrom the control system 300. In another embodiment of the invention, theinterface module 308 comprises an additional structure, such as a plug,for charging a battery powering the control system 300, such as at homeor in a vehicle. In other embodiments of the invention, the interfacemodule 308 may also communicate directly or indirectly with componentsof the control system 300 other than the CPU 305.

The control drive module 310 is used to translate high-level plans orinstructions received from the CPU 305 into low-level control signals tobe sent to the actuator 316. In one embodiment, the control drive module310 comprises a printed circuit board that implements control algorithmsand tasks related to the management of the actuator 316. In addition,the control drive module 310 may be used to implement a hardwareabstraction layer that translates the decision processes of the CPU 305to the actual hardware definition of the actuator 316. In anotherembodiment of the invention, the control drive module 310 may be used toprovide feedback to the CPU 305 regarding the position or movement ofthe actuator 316 or ankle device 304. The control drive module 310 mayalso be used to adjust the actuator 316 to a new “neutral” setting upondetection by the CPU 305 that the user is traveling on an angledsurface.

In one embodiment of the invention, the control drive module 310 islocated within the ankle device 304. In other embodiments, the controldrive module 310 may be located on the outside of the ankle device 304,such as on a socket, or remote to the ankle device 304.

The actuator 316 provides for the controlled movement of the ankledevice 304. In one embodiment, the actuator 316 functions similarly tothe actuator 116 described with respect to FIGS. 1-6, which actuator 116controls the ankle motion of the prosthesis 100. In other embodiments ofthe invention, the actuator 316 may be configured to control the motionof an orthotic device, such as a brace or other type of supportstructure.

The ankle device 304 comprises any structural device that is used tomimic the motion of a joint, such as an ankle, and that is controlled,at least in part, by the actuator 316. In particular, the ankle device304 may comprise a prosthetic device or an orthotic device.

The power module 318 includes one or more sources and/or connectorsusable to power the control system 300. In one embodiment, the powermodule 318 is advantageously portable, and may include, for example, arechargeable battery, as discussed previously. As illustrated in FIG. 9,the power module 318 communicates with the control drive module 310 andthe CPU 305. In other embodiments, the power module 318 communicateswith other control system 300 components instead of, or in combinationwith, the control drive module 310 and the CPU 305. For example, in oneembodiment, the power module 318 communicates directly with the sensormodule 302. Furthermore, the power module 318 may communicate with theinterface module 308 such that a user is capable of directly controllingthe power supplied to one or more components of the control system 300.

The components of the control system 300 may communicate with each otherthrough various communication links. FIG. 9 depicts two types of links:primary communication links, which are depicted as solid lines betweenthe components, and secondary communication links, which are depicted asdashed lines. In one embodiment, primary communication links operate onan established protocol. For example, the primary communication linksmay run between physical components of the control system 300. Secondarycommunication links, on the other hand, may operate on a differentprotocol or level than the primary communication links. For example, ifa conflict exists between a primary communication link and a secondarycommunication link, the data from the primary communication link willoverride the data from the secondary communication link. The secondarycommunication links are shown in FIG. 9 as being communication channelsbetween the control system 300 and the environment. In other embodimentsof the invention, the modules may communicate with each other and/or theenvironment through other types of communication links or methods. Forexample, all communication links may operate with the same protocol oron the same level of hierarchy.

It is also contemplated that the components of the control system 300may be integrated in different forms. For example, the components can beseparated into several subcomponents or can be separated into moredevices that reside at different locations and that communicate witheach other, such as through a wired or wireless network. For example, inone embodiment, the modules may communicate through RS232 or serialperipheral interface (SPI) channels. Multiple components may also becombined into a single component. It is also contemplated that thecomponents described herein may be integrated into a fewer number ofmodules. One module may also be separated into multiple modules.

Although disclosed with reference to particular embodiments, the controlsystem 300 may include more or fewer components than described above.For example, the control system 300 may further include an actuatorpotentiometer usable to control, or fine-tune, the position of theactuator 316. The user may also use the actuator potentiometer to adjustthe heel height of the ankle device 304. In one embodiment, the actuatorpotentiometer communicates with the CPU 305. In other embodiments, thecontrol system 300 may include a vibrator, a DC jack, fuses,combinations of the same, or the like.

Examples of similar or other control systems and other relatedstructures and methods are disclosed in U.S. patent application Ser. No.10/463,495, filed Jun. 17, 2003, entitled “ACTUATED LEG PROSTHESIS FORABOVE-KNEE AMPUTEES,” now published as U.S. Publication No.2004/0111163; U.S. patent application Ser. No. 10/600,725, filed Jun.20, 2003, entitled “CONTROL SYSTEM AND METHOD FOR CONTROLLING ANACTUATED PROSTHESIS,” now published as U.S. Publication No.2004/0049290; U.S. patent application Ser. No. 10/627,503, filed Jul.25, 2003, entitled “POSITIONING OF LOWER EXTREMITIES ARTIFICIALPROPRIOCEPTORS,” now published as U.S. Publication No. 2004/0088057; andU.S. patent application Ser. No. 10/721,764, filed Nov. 25, 2003,entitled “ACTUATED PROSTHESIS FOR AMPUTEES,” now published as U.S.Publication No. 2004/0181289; each which is herein incorporated byreference in its entirety and is to be considered as part of thisspecification. In addition, other types of control systems that may beused in embodiments of the present invention are disclosed in U.S.Provisional Application No. 60/551,717, entitled “CONTROL SYSTEM FORPROSTHETIC KNEE,” filed Mar. 10, 2004; U.S. Provisional Application No.60/569,511, entitled “CONTROL SYSTEM AND METHOD FOR A PROSTHETIC KNEE,”filed May 7, 2004; and U.S. Provisional Application No. 60/572,996,entitled “CONTROL SYSTEM AND METHOD FOR A PROSTHETIC KNEE,” filed May19, 2004, which are herein incorporated by reference in their entiretiesto be considered as part as this specification.

FIG. 10 is a table that depicts possible control signals that may beinvolved in adjusting the ankle angle of a prosthetic or orthotic devicewhen a user is transitioning between different states, or types oflocomotion, according to one embodiment of the invention. In particular,the states listed in a column 402 identify a first state of the user,and the states listed in a row 404 identify a second state of the user,or the state to which the user is transitioning. The remainder of thetable identifies possible actions that may be taken by the prosthetic ororthotic device with respect to the ankle angle. “User set point” is theneutral, or default, value that may be set during shoe heel heightadjustment. The angles specified are examples of changes to the ankleangle of the prosthetic or orthotic device. For example, when a user istransitioning from a “stance” state to an “ascending stairs” state, theankle angle may be adjusted to the angle of the stairs, such as forexample, −10 degrees (or 10 degrees dorsiflexion). Ankle angles given inthe “Incline (up)” and “Decline” columns reflect threshold levels ofankle angle adjustment depending on the angle of the incline.

The following table (TABLE 2) illustrates possible ankle motionstrategies for one embodiment of the invention. The first column ofTABLE 2 lists different types of locomotion types or gait patterns thatmay be frequently detected. The second column of TABLE 2 identifiesexamples of ankle angle adjustment of the prosthetic or orthotic deviceduring the swing phase of each of the identified locomotion types. TABLE2 Locomotion Type/Gait Pattern Ankle Motion During Swing Phase of AnkleDevice Level Ground Toe clearance during swing Walking Ascending StairsAnide adjusts to dorsiflexion (e.g., 7.5°) Descending Stairs Ankleadjusts to dorsiflexion (e.g., 5°) Incline (up) Ankle adjust todorsiflexion: a) Two incline angle threshold levels (x°, y°) b) Stepwise(2 steps) angle adjustment (z°, w°)  - Example: If incline angle > x°,ankle will adjust to  −z°; if incline angle > y°, ankle will adjust to−w°,  wherein x = 2.5° and y = 5°. Decline Ankle adjusts toplantarfiexion: a) Two decline angle threshold levels (x°, y°) b)Stepwise (2 steps) angle adjustment (z°, w°)  - Example: If declineangle > x°, ankle will adjust to  z°; if decline angle > y°, ankle willadjust to w°,  wherein x = 2.50 and y = 5° Sitting/Relaxed Set HeelHeight Adjust Heel Stepless heel height adjustment up to Height 20°plantarflexion

FIG. 11 depicts a graph that illustrates the interaction andrelationship between the control of a prosthetic or orthotic leg and themeasurements taken from a healthy, sound leg. In particular, FIG. 11depicts the movement of a prosthetic or orthotic leg and a healthy legduring one full stride of a user. For example, during approximately thefirst 60% of the stride, the graph shows the prosthetic or orthotic legas being in a “stance” position or being planted on a surface, such asthe ground. In one embodiment, during the beginning portion of thestance phase the ankle angle of the prosthetic or orthotic leg maydecrease (dorsiflexion). Toward the end of the stance phase the ankleangle of the prosthetic or orthotic leg may then increase(plantarflexion) to facilitate natural stride movements. In otherembodiments of the invention, the ankle angle of the prosthetic ororthotic leg is not actively adjusted during the stance phase. During aportion of this same period, up to approximately point 40%, the healthyleg may be in a swinging position, wherein the healthy leg is not incontact with the ground. Between the points of approximately 40% and60%, both legs are in contact with the ground.

From approximately point 60% to 100% (the end of the stride), theprosthetic or orthotic leg is in a swinging position, and the healthyleg is in contact with the ground. The graph in FIG. 11 shows that theankle angle of the prosthetic or orthotic leg is adjusted during theswing phase. This angle adjustment may be based on previous measurementsof the healthy leg during the swing phase of the healthy leg. In oneembodiment, during the beginning portion of the swing phase of theprosthetic or orthotic leg, the ankle angle of the prosthetic ororthotic leg may decrease. This allows, for example, a toe portion ofthe prosthetic or orthotic leg to clear stairs. Toward the latterportion of the swing phase of the prosthetic or orthotic leg, the ankleangle of the prosthetic or orthotic leg may then increase beforecontacting the ground. In other embodiments, the angle adjustment isbased on readings taken by sensors on the prosthetic side.

It is to be understood that FIG. 11 is illustrative of the functioningof one embodiment of the invention under certain conditions. Otherembodiments or circumstances may require a longer or shorter stance orswing phase and require other adjustments to the angle of the ankleportion of the prosthetic leg.

While certain embodiments of the inventions have been described, theseembodiments have been presented by way of example only, and are notintended to limit the scope of the inventions. Indeed, the novel methodsand systems described herein may be embodied in a variety of otherforms. For example, the foregoing may be applied to the motion-controlof joints other than the ankle, such as a knee or a shoulder.Furthermore, various omissions, substitutions and changes in the form ofthe methods and systems described herein may be made without departingfrom the spirit of the inventions. The accompanying claims and theirequivalents are intended to cover such forms or modifications as wouldfall within the scope and spirit of the inventions.

1. A method for controlling a device associated with the movement of alimb, the method comprising: monitoring with at least one sensor themovement of an actuatable device associated with a limb; generating dataindicative of said movement; processing the data with a processingmodule to determine a current state of locomotion of the actuatabledevice; and adjusting the actuatable device based on the determinedstate of locomotion, wherein said adjusting comprises substantiallymimicking the movement of a healthy ankle.
 2. The method of claim 1,wherein the actuatable device comprises an orthotic device.
 3. Themethod of claim 1, wherein the actuatable device comprises a prostheticdevice.
 4. The method of claim 1, additionally comprising determining asecurity factor, wherein adjusting the actuatable device occurs only ifthe security factor exceeds a pre-determined threshold.
 5. The method ofclaim 1, additionally comprising substantially locking the actuatabledevice in a fixed position when a battery power level drops below apredetermined threshold.
 6. The method of claim 1, wherein the at leastone sensor is located on the actuatable device.
 7. The method of claim1, wherein adjusting the actuatable device comprises extending andcontracting an actuator.
 8. The method of claim 1, additionallycomprising adjusting a heel height of the actuatable device.
 9. Themethod of claim 1, wherein the at least one sensor is located on thelimb.
 10. A method for controlling a prosthetic ankle device, the methodcomprising: monitoring with at least one sensor the movement of anactuatable prosthetic ankle device, wherein the at least one sensorgenerates data indicative of the movement of the prosthetic ankledevice; receiving and processing the data with a control module todetermine a current state of locomotion of the actuatable prostheticankle device; outputting with the control module at least one controlsignal based on the determined state of locomotion; and adjusting theactuatable prosthetic ankle device based at least upon the controlsignal, wherein said adjusting comprises substantially mimicking themovement of a healthy ankle.
 11. The method of claim 10, additionallycomprising receiving and processing data indicative of at least oneterrain variable.
 12. The method of claim 10, wherein substantiallymimicking the movement of a healthy ankle comprises movement of theactuatable prosthetic ankle device from approximately ten degreesdorsiflexion to approximately twenty degrees plantarflexion.
 13. Themethod of claim 10, wherein the at least one sensor is positioned on theprosthetic ankle device.
 14. The method of claim 13, wherein the atleast one sensor comprises at least one accelerometer.
 15. The method ofclaim 10, wherein monitoring the movement of an actuatable prostheticankle device comprises monitoring movement of the actuatable prostheticankle device in three different axes.
 16. The method of claim 10,additionally comprising providing dampening to counteract unwantedmovements of the actuatable prosthetic ankle device.
 17. The method ofclaim 10, additionally comprising substantially locking the actuatableprosthetic ankle device at a fixed angle when a power source associatedwith the actuatable prosthetic ankle device falls below a particularthreshold power level.
 18. The method of claim 10, additionallycomprising receiving from a user a second signal indicative of a heelheight adjustment.
 19. The method of claim 10, wherein adjusting theactuatable prosthetic ankle device comprises causing rotation about apivot point of the prosthetic ankle device.
 20. The method of claim 11,wherein the at least one terrain variable includes data indicative of aslope of the ground surface.